Gastric Ultrasound in Term Pregnants

NCT06493110 | Completed

• 1 other identifier: 2022/26-12
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Conditions

Pregnancy; Diabetes

Keywords

Gastric ultrasound; Term pregnant; Preoperative fasting

Outcome Measures

Primary Outcomes (1)

• Gastric Antrum Quality

  Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows: Grade 0: The stomach appears empty in both supine and right lateral decubitus positions. Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position. Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions.

  12 months

Secondary Outcomes (3)

• Gastric Volume

  12 months

• Aspiration Risk

  12 months

• Preoperative Anxiety Effect

  12 moths

Study Arms (2)

diabetic term pregnant

1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent

Procedure: Gastric ultrasound

non-diabetic term pregnant

1. Patients with good mental status 2. Pregnant patients aged ≥18 years 3. Patients in ASA II-III group 4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids) 5. Term pregnant women (gestational age ≥ 36 weeks) 6. 50-120kg weight 7. 150cm height or taller 8. Have written informed consent

Procedure: Gastric ultrasound

Interventions

Gastric ultrasound PROCEDURE

To compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound.

diabetic term pregnant; non-diabetic term pregnant

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This cohort comprised 30 diabetic and 30 non-diabetic individuals. The included participants were mentally healthy, aged 18 and above, classified as ASA II-III according to the American Society of Anesthesiologists, and had a gestational age of 36 weeks or more.

You may qualify if:

• Patients with good mental status
• Pregnant patients aged ≥18 years
• Patients in ASA II-III group
• Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
• Term pregnant women (gestational age ≥ 36 weeks)
• kg weight
• cm height or taller
• Written informed consent

You may not qualify if:

• Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
• Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
• Pregnant women with term labor or obstetric emergency
• Twin pregnancy -

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

KahramanmarasSIU

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: July 9, 2024
• Study Start: March 12, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)